Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing

NCT06674564 | Active Not Recruiting DMC

• 1 other identifier: zn probiotics laryngeal cancer
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.

Conditions

Laryngectomy

Keywords

laryngeal cancer , zinc , probiotics, total laryngectomy

Outcome Measures

Primary Outcomes (4)

• wound healing

  The role of zinc and probiotics supplementations on the rate of wound healing (pharyngeal reconstruction.

  21 days after surgery, a month total

• occurrence of percutaneous fistula

  according to john et al grading 3- 4 grade

  21 days after surgery - total a month

• rate of infections

  rate of infection of wound after total /partial laryngectomy

  21 days after surgery - a month total

• starting of oral feeding

  reconstruction of pharynx post operative and start oral feeding

  21 days after surgery-30 days total

Secondary Outcomes (2)

• length of hospital stay

  month from start , 21 days after surgery

• evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events.

  21-days post surgery month total

Study Arms (4)

control group

NO INTERVENTION

patients in this group will not having any interventions except the usual treatment before and after surgery

zinc group

ACTIVE COMPARATOR

patients in this group will take 50 mg zinc sulfate beside the usual treatment

Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule

probiotics group

ACTIVE COMPARATOR

patients in this group will take probiotics beside the usual treatment

Dietary Supplement: Probiotic

zinc and probiotics proup

ACTIVE COMPARATOR

patients in this group will take zinc and probiotics beside the usual treatment

Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule; Dietary Supplement: Probiotic

Interventions

Zinc Acetate 50 Mg Oral Capsule DIETARY_SUPPLEMENT

zinc suppose to improve immunity and wound healing after laryngectomy

zinc and probiotics proup; zinc group

Probiotic DIETARY_SUPPLEMENT

probiotics lowering infections rates and improving outcomes after surgery

probiotics group; zinc and probiotics proup

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to ENT department will be subjected eligible Adults patients newly diagnosed at outpatient clinic with laryngeal cancer at any stage and will undergo total/partial laryngectomy surgery.
• Patients with Level of hemoglobin \>9 mg/dl and serum albumin 3g/dl According to (Crosetti et al. 2021).
• Staging of laryngeal cancer according to the American Joint Committee on Cancer (AJCC) 8th edition by TNM system.

You may not qualify if:

• \- 1. Impaired renal function sr.cr≤2.5 (zinc clearance). 2.Previous history of cancer diseases in other sites( previous chemotherapy or radiation).
• Hypersensitivity to probiotics and zinc.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospital

Cairo, Al Abbasya, 11252, Egypt

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Zinc Acetate; Probiotics

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• botamina nabil

  pharmacy ASU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open labelled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: November 5, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)